Electroporation device with detachable needle array with locking system

Abstract

The present invention provides an electroporation device having a detachable needle array with a locking system. The electroporation device has a needle array removably attached thereto, the needle array having a body, a shield movable between a rest position and one or more actuated positions relative to the body, and an automatic locking assembly. The automatic locking assembly is adjustable between a locked configuration and an unlocked configuration, in which the shield is immovable relative to the body and in which the shield is movable relative to the body, and wherein biasing the shield from the rest position to the one or more actuated positions and back to the rest position adjusts the automatic lock from the unlocked configuration to the locked configuration.

Description

[0001] This application is a divisional application of Chinese patent application No. 201680080899X, whose application date is December 30, 2016 and whose invention name is “Electroporation device with a detachable needle array with a locking system”.

[0002] CROSS-REFERENCE TO RELATED APPLICATIONS

[0003] This patent application claims priority to U.S. Provisional Patent Application No. 62 / 272,758, filed on December 30, 2015. The above-referenced applications are incorporated herein by reference. Technical Field

[0004] The present invention relates to a detachable needle array for use on an electroporation device, and more particularly to a detachable needle array having two independent needle locking mechanisms. Background Art

[0005] Modern medical treatments (such as electroporation, injections, etc.) often require the use of some form of needle, electrode, or other form of sharp instrument. During use, these items may contact or be inserted into the patient's body, resulting in the items being contaminated by the patient's tissues and body fluids. Even after the items have been removed from the patient and are no longer used, they still pose a variety of safety hazards to clinicians and patients. Some safety hazards may include cross contamination, needle sticks, etc.

[0006] In addition, the electroporation process requires the use of different sharps at different times. For example, a hypodermic needle may be initially required in order to inject an agent into the target tissue, but then the hypodermic needle may no longer be required when the electroporation signal is applied. Due to these elements of the electroporation process, it may be necessary to lock various sets and subsets of elements (i.e., sharps) independently of each other. Such capabilities not only provide more control and flexibility during the electroporation process, they also provide a safer means of ensuring that any elements that are no longer needed are securely locked and cannot come into contact with the target tissue. Summary of the invention

[0007] In one aspect, an electroporation device comprises: a handset, wherein the handset comprises: a housing defining a mounting point, and a signal generator positioned within the housing. The electroporation device also comprises a needle array removably coupled to the mounting point and in electrical communication with the signal generator when the needle array is coupled to the mounting point, the needle array comprising: a body; a shield movable between a rest position and one or more actuated positions relative to the body; an automatic lock adjustable between a locked configuration and an unlocked configuration, wherein the shield is not movable relative to the body in the locked configuration and the shield is movable relative to the body in the unlocked configuration, and wherein biasing the shield from the rest position to the one or more actuated positions and back to the rest position adjusts the automatic lock from the unlocked configuration to the locked configuration.

[0008] In another aspect, an electroporation device includes a handset, the handset including: a housing defining a mounting point, a power source; and a signal generator in electrical communication with the power source. The electroporation device also includes a needle array releasably coupled to the mounting point of the housing, the needle array including: a body; one or more electrodes coupled to the body; a shield movable between a rest position and one or more actuated positions relative to the body, and wherein at least a portion of the one or more electrodes are positioned outside the shield when the shield is in each of the one or more actuated positions; a receiver movable between an injection position and a retracted position relative to the body, the receiver having a hypodermic needle extending therefrom; and a locking pin coupled to one of the body and the receiver and movable relative thereto between a locked position and an unlocked position, wherein the receiver is fixed relative to the body in the locked position, and wherein the receiver is movable relative to the body in the unlocked position, and wherein the locking pin is biased toward the locked position so that when the receiver is positioned in a predetermined position relative to the body, the locking pin moves into the locked position.

[0009] In yet another aspect, an electroporation system for performing electroporation therapy, the system comprising: a base station; and a handset movably coupled to the base station. The handset comprises: a housing having a mounting formed thereon, a power source positioned within the housing, and an injection assembly having a release member thereon. The electroporation system further comprises: a needle array releasably coupled to the mounting of the housing, the needle array comprising: a body; one or more electrodes coupled to the body; a shield movable between a rest position and one or more actuated positions relative to the body, and wherein at least a portion of the one or more electrodes is exposed when the shield is in the one or more actuated positions; and an automatic lock adjustable between a locked configuration and an unlocked configuration, wherein the shield is not movable relative to the body in the locked configuration, and wherein the shield is movable relative to the body in the unlocked configuration, and wherein biasing the shield from the rest position to the one or more actuated positions and back to the rest position adjusts the automatic lock from the unlocked configuration to the locked configuration. BRIEF DESCRIPTION OF THE DRAWINGS

[0010] Figure 1 is a perspective view of the electroporation handpiece.

[0011] Figure 1a is a perspective view of an electroporation handset coupled to a base station.

[0012] Figure 2 Show Figure 1 The drive assembly of the electroporation handpiece.

[0013] Figure 3 is a perspective view of the array with the receivers in the retracted position.

[0014] Figure 4 It is cut along the central axis Figure 3 A cross-sectional view of an array.

[0015] Figure 5 It is cut along the central axis Figure 3 A cross-sectional view of an array.

[0016] Figure 6 yes Figure 3 Rear view of the array.

[0017] Figure 7 yes Figure 3 Rear perspective view of the array.

[0018] Figure 8 is a rear perspective view of the array with the receiver in the injection position.

[0019] Fig. 9 yes Figure 8 A cross-sectional view of an array.

[0020] Fig.10 yes Figure 8 Rear view of the array.

[0021] Fig.11 yes Figure 8 Exploded view of an array.

[0022] Fig.12 yes Figure 8 A perspective view of an array of wherein the cover is shown as transparent to illustrate the automatic locking assembly in a needle-free configuration.

[0023] Fig.13 yes Fig.12 A perspective view of an array showing the automatic locking assembly in a needle configuration.

[0024] Fig.14 yes Fig.12 A perspective view of an array of FIG. 1 showing an automatic locking member in a locked configuration.

[0025] Figures 15A-15C yes Fig.12 A top view of an array showing automatic locking members in various configurations.

[0026] Fig.16 is a perspective view of the stopper.

[0027] Fig.17 is a schematic diagram of the receiver in the injection position.

[0028] Fig.18 is a schematic diagram of the receiver in the retracted position.

[0029] Fig.19 yes Figure 1 Front perspective view of a handset.

[0030] Fig. 20 yes Figure 1 A perspective view of the trigger of a handset. DETAILED DESCRIPTION

[0031] "Agent" may refer to a polypeptide, a polynucleotide, a small molecule, or any combination thereof. As described in detail in PCT / US2014 / 070188, an agent may be a recombinant nucleic acid sequence encoding an antibody, a fragment thereof, a variant thereof, or a combination thereof, and the patent application is incorporated herein by reference. "Agent" may refer to a composition comprising a polypeptide, a polynucleotide, a small molecule, or any combination thereof. As described in detail in PCT / US2014 / 070188, a composition may include a recombinant nucleic acid sequence encoding an antibody, a fragment thereof, a variant thereof, or a combination thereof, and the patent application is incorporated herein by reference. For example, the agent may be prepared in water or a buffer. For example, the buffer may be saline-sodium citrate (SSC) or phosphate buffered saline (PBS). The ion content of the buffer may increase conductivity, thereby causing an increase in the current in the target tissue. The concentration of the polynucleotides prepared may be between 1 μg and 20 mg / ml. For example, the polynucleotide may be formulated at a concentration of 1 μg / ml, 10 μg / ml, 25 μg / ml, 50 μg / ml, 100 μg / ml, 250 μg / ml, 500 μg / ml, 750 μg / ml, 1 mg / ml, 10 mg / ml, 15 mg / ml or 20 mg / ml.

[0032] As used herein, "peptide," "protein," or "polypeptide" may mean a linked sequence of amino acids, and may be natural, synthetic, or a modification or combination of natural and synthetic.

[0033] As used herein, "polynucleotide" or "oligonucleotide" or "nucleic acid" means at least two nucleotides covalently linked together. A polynucleotide may be single-stranded or double-stranded or may contain portions of both double-stranded or single-stranded sequences. A polynucleotide may be DNA, genomic and cDNA, RNA or a hybrid. A polynucleotide may contain a combination of deoxyribonucleotides and ribonucleotides, and a combination of bases, including uracil, adenine, thymine, cytosine, guanine, inosine, xanthine hypoxanthine, isocytosine, isoguanine, and synthetic or non-naturally occurring nucleotides and nucleosides. A polynucleotide may be a vector. A polynucleotide may be obtained by chemical synthesis or by recombinant methods.

[0034] As used herein, "vector" means a nucleic acid sequence containing a replication origin. The vector may be a viral vector, a bacteriophage, a bacterial artificial chromosome, or a yeast artificial chromosome. The vector may be a DNA or RNA vector. The vector may be a self-replicating extrachromosomal vector, and is preferably a DNA plasmid.

[0035] As used herein, the term "electroporation" ("EP") refers to the use of electric field pulses to induce reversible microscopic pathways (pores) in biological membranes; the presence of which allows agents to be transferred from one side of the cell membrane to the other.

[0036] Electroporation devices with detachable needle arrays of the present invention provide increased ease of use for nurses, doctors or technicians administering treatments, while also providing increased safety precautions. With regard to safety, the detachable needle array contains all needles and other surfaces that come into contact with the patient. The array also includes a locking assembly that allows the needles and electrodes to be exposed only once. Therefore, the array cannot be used on more than one patient, thereby preventing cross contamination of clinicians and patients. Further, by limiting the ability of needles to reappear from the array, the needle array can substantially prevent needle sticks. In addition, by locking various subsets of sharps individually, each subset can be locked after being removed from the target tissue without affecting the use of the remaining sharps. The array also includes the ability to keep a cartridge containing a reagent therein to ensure that the cartridge is only pierced and used once.

[0037] The present disclosure relates to a detachable needle array 22 for use with a handheld electroporation assembly (EP assembly). Specifically, the EP assembly 10 is operable for use in clinical and commercial environments to administer medical treatments to patients in the form of direct injections and electroporation. The EP assembly 10 includes a handset 18 and a base station 12 to which the detachable needle array 22 can be coupled. (See Figure 1a The base station 12 is typically located on a table or other flat surface and is in electrical communication with and capable of charging the power supply 24 of the handset 18 when the handset 18 and the base station 12 are in a docked or coupled configuration.

[0038] The handset 18 of the EP assembly 10 is operable to administer medical treatment to a patient. The handset 18 includes a housing 26, a power source 24 at least partially positioned within the housing 26, a signal generator 28 in electrical communication with the power source 24, a trigger 214 for selectively activating the signal generator 28, and a drive assembly 34. In the illustrated construction, the housing 26 forms a mount 86 to which the array 22 is attached.

[0039] like Figure 1 As shown, the housing 26 of the handset 18 is formed of two halves or members 32 that are coupled together to form a volume 36 therebetween. Specifically, the member 32 forms a pistol shape having an upper portion 40 with a front end 44 and a rear end 48, and a handle portion 52 extending from the upper portion 40 to form a distal end 56. Although the housing 26 is shown as a pistol shape, it should be understood that the housing 26 may include other shapes or accommodate different grip types.

[0040] like Fig.19As shown, the mounting member 86 of the housing 26 includes a rib 106 that is positioned radially outward and extends axially along the outer surface of the mounting member 86. The rib 106 is substantially rectangular in cross-section and is shaped to be at least partially received within a channel 110 (described below) of the array 22. The rib 106 is configured to cooperate with the channel 110 to properly orient the array 22 on the mounting member 86.

[0041] like Fig.19 As shown, the handset 18 also includes a plurality of sensors 146 , 150 , each of which is integrated into the housing 26 and is configured to collect and provide various types of information regarding the configuration of the array 22 .

[0042] like Fig.19 As shown, the handset 18 includes an array sensor 146 that is positioned proximate the leading edge of the mount 86 and is configured to detect when the array 22 is mounted thereon. Specifically, the array sensor 146 includes an optical sensor that is "covered" by the array 22, thereby indicating that the array 22 is properly mounted on the mount 86. The handset 18 also includes a shield sensor 150 that is positioned on the rib 106 of the mount 86 and axially positioned behind the array sensor 146. During use, the shield sensor 150 is configured to detect the position of the shield 350 relative to the array 22 (described below). Specifically, the shield sensor 150 is operable to verify that the shield 350 has been retracted a minimum distance (i.e., greater than about 5 mm) to ensure that the current is properly delivered to the target tissue without causing burns, etc. The handset 18 also includes a pair of depth sensors (not shown) that are operable to record the position of the depth limiter 186 and determine its current depth setting.

[0043] like Figure 2 As shown, the drive assembly 34 of the handset 18 is positioned within the volume 36 and is operable to selectively engage the array 22 and cause the drug to be injected directly into the patient. The drive assembly 34 includes a motor 162 and an injection rod 158 driven by the motor 162. As described below, the motor 162 specifies the rotation speed and rotation direction of the drive gear 166. The rotation of the drive gear 166 is then transmitted to the injection rod 158.

[0044] The injection rod 158 of the drive assembly 34 is an elongated generally cylindrical rod that is mounted for reciprocating motion relative to the housing 26. The injection rod 158 is coaxially located with the mount and can be translated coaxially with the mount in a first direction D generally into the array 22 (i.e., for administering medication) and can be translated coaxially with the mount in a second direction E generally away from or away from the array 22 (i.e., for administering medication). Figure 2 ).

[0045] The injection rod 158 also includes a release member 174 that is positioned a distance from the contact end 178 and is configured to engage a locking pawl 182 (described below) of the array 22. During use, the release member 174 is positioned a distance from the contact end 178 of the injection rod 158 and fixed thereto. The release member 174 is positioned a specified distance from the contact end 178 so that the release member 174 does not engage the locking pawl 182 of the array 22 until after the drug has been dispensed. In an alternative configuration, the release member 174 can be controlled independently of the injection rod 158, thereby allowing the handset 18 to release the locking pawl 182 independently of the injection process (not shown).

[0046] like Fig.19 and Fig. 20 As shown, the handpiece 18 of the electroporation device includes a depth assembly 38. More specifically, the handpiece 18 includes a depth limiter or trigger 186, which is coupled to the housing 26 and is configured to allow a user to set a maximum injection depth of the array 22. Specifically, the trigger 186 can be adjusted between a plurality of (i.e., three) depth settings, wherein each depth setting corresponds to a specific target injection depth. In the illustrated structure, the position of the trigger 186 is recorded by a first depth sensor and a second depth sensor to ensure that the electroporation treatment is performed at an appropriate depth for the particular patient.

[0047] like Fig. 20 As shown, the trigger 186 of the handset 18 includes a cam or linear table 190, which in turn defines three different contact points 194a, 194b, 194c, each of which corresponds to a different target injection depth setting. During use, the user can move the trigger 186 relative to the housing 26 so that the different contact points 194a, 194b, 194c are axially aligned with the depth axis 406 of the array 22 (i.e., aligned with the orifice 200). In the illustrated structure, the first contact point 194a is configured to provide a target injection depth of approximately 13 mm, the second contact point 194b is configured to provide a target injection depth of approximately 19 mm, and the third contact point 194c is configured to provide a target injection depth of approximately 25 mm. Although the trigger 186 of the illustrated structure includes three contact points, it should be understood that more or fewer contact points may be used. In addition, the continuous waveform surface can be used for unlimited depth settings.

[0048] Still further, the handset 18 or base station 12 may include a controller 204 to calculate a desired target injection depth based on various factors, including, but not limited to, the patient's weight, the patient's height, the type of electroporation being administered, the size of the array, the reagent being administered, the location of the injection site, etc. Still further, the controller 204 may also set an operational envelope based at least in part on the calculated target injection depth. For example, the device may limit the allowable injection depth settings (i.e., those settings that allow the electroporation process to proceed) to those settings that fall within a particular range of calculated injection settings. This allows the user to have some flexibility in administering the electroporation treatment, but avoids drastic changes that may be considered unsafe.

[0049] like Figure 1 and Figure 3-11 As shown, the array 22 is removably connected to the handset 18 and is operable to provide a disposable interface between the handset 18 and the patient to minimize cross contamination and needle sticks. More specifically, the array 22 provides the necessary interface to allow the handset 18 to directly inject prescription drugs into the patient and apply electrical pulses to provide electrical perforation, while also having multiple "locking" mechanisms to prevent any needles or electrodes from reappearing from the array 22. Specifically, the locking mechanisms of the array 22 can be operated independently of each other, so that a specific portion, type or group of needles and / or electrodes can be locked, while the remaining portion of the needles or electrodes can remain unlocked and usable. In an alternative structure, the locking mechanism may operate in "layers", so that a first locking mechanism can disable a portion of the needles or electrodes, and a second locking mechanism can disable all needles or electrodes, regardless of the status of the other first locking mechanisms. In other other structures, the array 22 may include some combination thereof. The array 22 of the EP assembly 10 includes a body 346 , a shield 350 movably coupled to the body 346 , and a needle assembly 354 .

[0050] The body 346 of the array 22 is substantially truncated in shape defining a central axis 358 therethrough. The body 346 is formed by a substantially annular outer wall 362 having a first end 366 sized to correspond to the front end 54 of the handset housing 26, and a second end 370 opposite the first end 366. The body 346 also defines a pair of apertures 374 ( Figure 3 ), which are formed in the annular wall 362 and are positioned substantially opposite each other. When assembled, each aperture 374 is sized and shaped to receive at least a portion of the ejection button 126 (described below) therein.

[0051] The body 346 of the array 22 also includes a channel 110 formed in the annular wall 362 and extending axially between the first end 366 and the second end 370. When assembled, the channel 110 is sized to receive at least a portion of the shield 350 therein while allowing the shield 350 to slide axially therewith. The channel 110 also receives at least a portion of the handset 18 (i.e., the ribs 46) therein when the array 22 is mounted on the handset 18. The channel 110 of the array 22 helps to properly orient the array 22 relative to the handset 18.

[0052] like Figure 4-6 As shown, the array 22 also includes a subframe 378 positioned within the annular wall 362 and fixedly coupled thereto. In the illustrated construction, the subframe 378 includes an inner surface 382 that defines an inner diameter that substantially corresponds to the outer diameter of the mount. When the array 22 is mounted on the handset 18, the mount is at least partially received within the subframe 378. In this manner, the subframe 378 and the mount position the array 22 coaxially with the mount.

[0053] The subframe 378 also includes a pair of ejection buttons 126 that are configured to selectively engage the mounting member 86 and secure the array 22 thereto. Each ejection button 126 is pivotally coupled to the subframe 378 near its center and includes a first end 386 and a second end 390 opposite the first end 386. In the illustrated construction, the ejection buttons 126 are mounted to the subframe 378 such that biasing the first end 386 radially inward causes the second end 390 to be biased radially outward. When the array 22 is assembled, the first end 386 of the ejection button 126 is configured to be at least partially received within a corresponding aperture 374 of the annular wall 362 so that a user can access the button 126 during use.

[0054] like Figure 4 As shown, the shield 350 of the array 22 is substantially frustoconical in shape, having a contact plate 394 and an outer wall 398 extending axially from the contact plate 394 to create an open end 402. During use, the shield 350 can be in a stationary position ( Figure 4 ) and one or more actuation positions ( Fig.13 ), in which the contact plate 394 is a first distance from the second end 370 of the body 346, and in which the contact plate 394 is at least partially retracted into the body 346 in the one or more actuated positions. During use, a user places the contact plate 394 against a patient (i.e., against the skin of the patient in the area to be treated), thereby causing the user to move the contact plate 394 in direction C ( Figure 1) any force applied to the handset 18 by the user will cause the shield 350 to move from the rest position relative to the body 346 and into one or more actuated positions. Movement of the shield 350 from the rest position and toward one or more actuated positions (i.e., into the body 346) causes at least a portion of the needle assembly 354 to extend beyond the contact plate 394 and into the patient's body. Specifically, the greater the distance that the shield 350 is biased toward the second end 370 of the body 346 (i.e., the greater the force applied to the handset 18 by the user in direction C), the greater the distance that the needle assembly 354 extends beyond the contact plate 394 and the greater the resulting injection depth.

[0055] In the illustrated structure, the shield 350 is axially movable between a rest position and three distinct actuated positions. Specifically, the first actuated position generally corresponds to the first contact point 194a of the trigger 186 and allows the needle assembly 354 to extend beyond the contact plate 394 by a distance of 13 mm. In addition, the second actuated position generally corresponds to the second contact point 194b of the trigger 186 and allows the needle assembly 354 to extend beyond the contact plate 394 by a distance of 19 mm. Finally, the third actuated position generally corresponds to the third contact point 194c of the trigger 186 and allows the needle assembly 354 to extend beyond the contact plate 394 by a distance of 25 mm.

[0056] The shield 350 of the array 22 also includes a depth axis 406 extending axially from the open end 402 to create a distal end 410. During use, the distal end 410 of the depth axis 406 is positioned near the first end 366 of the body 346 and is configured to pass through the aperture 200 of the handpiece 18 and contact the cam surface 190 of the trigger 186 when the shield 350 has been biased to an actuated position that substantially corresponds to a desired injection depth. The depth axis 406 can also serve as a stop for the shield 350, thereby limiting the extent to which the shield 350 can move axially toward the body 346. In this way, by changing the contact point between the depth axis 406 and the trigger 186 (i.e., by adjusting the position of the trigger 186), the user is able to change the distance that the shield 350 can move relative to the body 346 and, therefore, can limit the maximum needle penetration into tissue.

[0057] The shield 350 also defines an injection orifice 414 near the center of the contact plate 394. The injection orifice 414 is sized to allow an injection needle 418 of the needle assembly 354 to pass therethrough and into a patient for treatment. In the illustrated construction, the injection orifice 414 is positioned on the inside of the contact plate 394 by an annular wall 422 that is sized to receive and position a syringe stopper 426 therein.

[0058] The shield 350 also defines a plurality of electrode apertures 430 located in the contact plate 394. Each electrode aperture 430 is sized to allow a corresponding one of the electrodes 142 (described below) to pass therethrough. Each electrode aperture 430 has a substantially tapered cross-section to facilitate guiding the corresponding electrode 142 through the aperture 430 and into the patient for treatment. In the illustrated construction, the shield 350 includes five (5) electrode apertures 430, each of which is centered at the injection aperture 414 ( Figure 3 ) is evenly spaced along the reference circle centered. However, in alternative structures, the shield 350 may include 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 or 12 electrode apertures in any number of electrode array patterns (such as square, triangle, oval, etc.).

[0059] The shield 350 also includes a retraction spring 434 extending between the shield 350 and the body 346 and configured to bias the shield 350 toward the rest position. In the illustrated construction, the retraction spring 434 is strong enough to avoid inadvertent exposure of the needle assembly 354, but weak enough to avoid requiring excessive force to expose the needle assembly 354 and inject the patient.

[0060] like Figure 4-5 As shown, the needle assembly 354 is fixedly coupled to the subframe 378 of the array 22 and is configured to orient a plurality of needles - in particular, the injection needle 418 and the plurality of electrodes 142 - for injection into a patient. The needle assembly 354 includes a needle body 438 fixedly coupled to the subframe 378 of the array 22, a plurality of electrodes 142 coupled to the needle body 438, and an injection assembly 442.

[0061] like Figure 4-5 As shown, the needle body 438 is substantially cylindrical in shape and has an injection end 446 and a loading end 450 opposite the injection end 446. When the array 22 is assembled, the needle body 438 is coaxially positioned with the axis 358, wherein the injection end 446 is positioned near the second end 370 of the body 346 and the loading end 450 is positioned near the first end 366 of the body 346.

[0062] The needle body 438 defines an internal passage 454 that extends coaxially therethrough and is open to both the injection end 446 and the loading end 450. The internal passage 454 includes: a first portion 458 proximate the loading end 450 defining a first diameter, and a second portion 462 proximate the injection end 446 defining a second diameter, the second portion being smaller than the first diameter. In the illustrated construction, the first portion 458 of the internal passage 454 is sized to receive at least a portion of the injection assembly 442 (described below) therein.

[0063] The needle body 438 also includes a locking pawl 182 positioned near the loading end 450 and configured to selectively retain the injection assembly 442 in the first portion 458 of the internal passage 454. During use, the locking pawl 182 can be in a locked position ( Figure 8 ) and unlock positioning ( Figure 6 ), in which the pawl 182 contacts the injection assembly 442, and in the unlocked position, the pawl 182 does not contact the injection assembly 442. Thus, when the locking pawl 182 is in the locked position, the injection assembly 442 cannot move axially relative to the needle body 438. In contrast, when the locking pawl 182 is moved to the unlocked position, the injection assembly 442 is free to move axially relative to the needle body 438.

[0064] Each electrode 142 of needle assembly 354 is mounted to needle body 438 and extends axially from injection end 446 to define a tip 470. During use, movement of shield 350 from the rest position toward the activated position causes each tip 470 to pass through a corresponding electrode aperture 430 and into the patient's body for treatment when contact plate 394 is pressed against the patient.

[0065] Each electrode 142 also includes a lead 474 extending from the electrode 142 opposite the tip 470. Each lead 474 is in electrical communication with its corresponding electrode 142 and passes through the needle body 438 to create an electrical contact 138 near the loading end 450. As described above, when the array 22 is mounted on the handset 18, each electrical contact 138 of the array 22 is configured to engage and form an electrical connection with a corresponding electrical contact (not shown) of the handset 18, and ultimately engage and form an electrical connection with the signal generator 28.

[0066] The needle assembly 354 of the array 22 also includes a first automatic locking mechanism 494. Figure 12-15C As shown, the needle assembly 354 includes an automatic lock 494 to limit the movement of the shield 350 relative to the body 346. More specifically, the automatic lock 494 is configured to lock the shield 350 in a static position (i.e., a position where the needle assembly 354 is not exposed) after the shield 350 has been biased beyond a predetermined "activation point". Specifically, once the shield 350 has been biased beyond the predetermined activation point, the automatic lock 494 becomes needle-engaged. After the automatic lock 494 is needle-engaged, any subsequent movement of the shield 350 into the static position will cause the shield 350 to become locked in place. In this way, the shield 350 can no longer move relative to the body 346, and the needle assembly 354 will not be exposed.

[0067] The auto-lock 494 limits the array 22 to a single use, allowing the user to expose the needle assembly 354 only once for treatment before the sheath 350 becomes locked and inoperable. In summary, the auto-lock 494 minimizes the chance of cross-contamination or inadvertent reuse of old arrays 22 or cartridges 498. The auto-lock 494 also reduces the chance of needle sticks by not allowing the injection needle 418 or electrode 142 to re-emerge from the shield 350 after its use.

[0068] like Figure 12-16 As shown, the automatic lock 494 includes a spring-like stopper 502 coupled to and movable with the shield 350, a locking surface 506 fixed relative to the body 346 of the array 22, and a protrusion 510 fixed relative to the body 346 and configured to selectively engage the stopper 502. As described above, the automatic lock 494 is configured to lock the shield 350 in place once it has exceeded a predetermined activation point so as to stop the needle assembly 352 from re-emerging from the shield 350 after it has been used.

[0069] like Fig.16 As shown, the stopper 502 of the automatic locking member 494 includes a substantially elastic body 512 having a first end 516 fixedly coupled to the shield 350, and a second end 520 opposite the first end 516 forming a locking tip 524. The body 512 of the stopper 502 is formed of a substantially elastic material (i.e., metal, plastic, etc.) to allow the body 512 to bend and allow the locking tip 524 to move relative to the first end 516. During use, the body 512 is configured so that the locking tip 524 is biased in the direction F and engages with at least one of the protrusion 510 and the locking surface 506 ( Fig.15A ) engagement. Thus, as the shield 350 moves relative to the body 346 of the array 22, the locking tip 524 will move along and remain engaged with the corresponding surface. In the illustrated construction, the locking tip 524 extends below the remainder of the stop 502 ( Fig.16 ) so that the tip 524 can remain in contact with and travel along the protrusion 510 and the locking surface 506 without causing any clearance or interference issues with the rest of the stopper 502.

[0070] The locking surface 506 of the automatic lock 494 is fixed relative to the body 346 of the array 22 and includes a first portion 528 positioned near the second end 370 of the body 346, and a second portion 532 extending from the first portion 528 toward the first end 366 of the body 346. As shown in FIG15A, the first portion 528 and the second portion 532 are offset from each other (i.e., positioned at different distances from the axis 358) to form an intermediate surface 536 therebetween. In the illustrated structure, the intermediate surface 536 forms a "Z" shape between the two portions 528, 532 to help retain the locking tip 524 of the stop 502 therein.

[0071] The protrusion 510 of the automatic lock 494 is fixed relative to the body 346 of the array 22 and defines a contact surface 540. The protrusion 510 is positioned away from the locking surface 506 and is configured to selectively engage the locking tip 524 of the stop 502 and position the tip 524 away from the locking surface 506 against the biasing force of the body 512. The rear edge 544 of the protrusion 510 defines an activation point for the automatic lock 494. The further rearward (i.e., toward the first end 366 of the body 346) the rear edge 544 is positioned, the further the shield 350 must be biased before the automatic lock 494 is engaged. During use, the locking tip 524 moves along the contact surface 540 of the protrusion 510 until the tip 524 exceeds the rear edge 544, at which point the locking tip 524 disengages from the protrusion 510 and is biased toward and engaged with the second portion 532 of the locking surface 506.

[0072] During operation of the automatic locking member 494, the locking tip 524 of the stop 502 initially engages the contact surface 540 ( Fig.12 and Fig.15A ), thereby positioning the tip 524 in a "needle-free" position 506 away from the locking surface. In the needle-free position, the locking tip 524 can move along the contact surface 540 of the protrusion 510 without restricting the movement of the shield 350 (i.e., the shield can be biased from the rest position to any point before the activation point and back.

[0073] When the user applies pressure to the handset 18 in direction C, the shield 350 is biased out of the rest position and toward the activated position. As a result, the tip 524 of the stopper 502 begins to move along the contact surface 540 of the protrusion 510 and toward the rear edge 544. When the tip 524 reaches the rear edge 544, the shield 350 has reached its activation point. At this point, the tip 524 passes the rear edge 544, disengages from the protrusion 510, and is biased into engagement with the second portion 532 of the locking surface 506 - thereby becoming a needle state ( Fig.13 and Fig. 15BOnce the needle is in place, the tip 524 of the stopper 502 remains engaged with the second portion 532 of the locking surface 506 and can continue to travel back and forth along its length.

[0074] When the user removes pressure from the handset 18, the shield 350 begins to return to the rest position. As a result, the tip 524 of the detent 502 begins to move along the second portion 532 of the locking surface 506 and toward the first portion 528. When the shield 350 is near the rest position, the tip 524 is biased out of engagement with the second portion 532 and into engagement with the first portion 528 of the locking surface 506 - thereby causing the shield 350 to become locked in place ( Fig.14 15C ). More specifically, any attempt to reapply force to the handset 18 in direction C will cause the tip 524 to engage the intermediate surface 506 and restrict any further movement away from the resting position. In this way, the shield 350 is restricted from moving relative to the body 346 and the needle assembly 354 will not be re-exposed.

[0075] While shown for use with array 22, it will be appreciated that automatic lock 494 may be implemented in other situations where sharps, such as needles and electrodes, are desired to limit access to and use of such items.

[0076] The array 22 also includes an independent needle retraction and lock for the injection point. The injection assembly 442 withdraws the injection needle 418 from the patient after the drug has been administered, while allowing the electrode 142 to remain inserted into the patient's body for continued treatment through electroporation. The injection assembly 442 is also used to lock the injection needle 418 in a retracted position after the initial injection has been performed to limit cross contamination and needle stick situations. The injection needle lock can be operated independently of the automatic locking mechanism 494. The injection assembly 442 includes a receiver 478 and an injection needle 418 connected to the receiver 478 to move therewith.

[0077] In the illustrated construction, the receiver 478 is substantially cylindrical in shape and is sized to be positioned axially within the first portion 458 of the internal passage 454 and to be positioned in the injection position ( Fig. 9 ) and the withdrawal position ( Figure 4 ), in which the receiver 478 is positioned proximate the injection end 446 of the needle body 438, and in which the receiver 478 is positioned away from the injection end 446 of the needle body 438. During treatment, movement of the receiver 478 between the injection position and the withdrawn position causes the injection needle 418 to move into and out of alignment with at least a portion of the one or more electrodes 142 ( Fig. 9More specifically, the injection needle 418 is sized so that when the receiver 478 is positioned at the injection site, the tip 482 of the needle 418 is aligned with the one or more electrodes 142 ( Fig. 9 ) is substantially aligned with at least a portion of the shroud 350. Thus, when the receiver 478 is in the injection position, the tip 482 of the needle 418 may be exposed or covered, depending on the position of the shroud 350 (described above). However, when the receiver 478 is in the retracted position, the tip 482 of the needle 418 may not be exposed regardless of the position of the shroud 350.

[0078] The injection needle 418 of the injection assembly 442 comprises a hypodermic needle beveled at both ends. When assembled, the first end 486 of the needle is positioned inside the receiver 478 and is configured to pierce the cartridge 498 inserted therein. In addition, the needle 418 extends axially from the receiver 478 to define an injection tip 482. When the receiver 478 is in the injection position, movement of the shield 350 from the rest position toward the activated position causes the injection tip 482 of the needle 418 to pass through the injection orifice 414 of the shield 350 and, when the contact plate 394 is pressed against the patient, enter the patient's body so that the drug contained in the cartridge 498 can be administered.

[0079] The injection assembly 442 also includes a spring 490 positioned in the first portion 458 of the internal passage 454 and extending between the receiver 478 and the needle body 438. During use, the spring 490 biases the receiver 478 away from the injection position and toward the withdrawal position. In the illustrated structure, the spring 490 must be strong enough to remove the injection needle 418 from the patient after the drug has been administered.

[0080] The injection assembly 442 also includes a locking pin 492 formed in the receiver 478 and arranged to be locked relative to the receiver 478 in an unlocked position ( Fig.17 ) and locked position ( Fig.18 ), in which the locking pin 492 is removed from the locking aperture 493 of the needle body 438 and the receiver 478 can move relative to the needle body 438, and in which the locking position the locking pin 492 is positioned within the locking aperture 493 and the receiver 478 is fixed relative to the needle body 438. During use, the locking pin 492 is biased toward the locked position so that when the locking aperture 493 becomes aligned with the pin 492, the pin 492 is biased into the locked position (i.e., enters the locking aperture 493). It should be understood that although the locking pin 492 is shown as being formed in the receiver 478 and the locking aperture 493 is formed in the needle body 438, the locking pin 492 can be formed in the needle body 438 and the locking aperture 493 can be formed in the receiver 478.

[0081] To remove the injection needle 418 from the patient, the user grasps the handset 18 and applies pressure in the direction C, thereby causing each of the electrode 142 and the injection needle 418 to pass over the contact plate 394 and enter the patient's body. It is worth noting that when the user applies pressure to the handset 18, the receiver 478 is held in the injection position by the locking claw 182 of the needle body 438 against the biasing force of the spring 490.

[0082] After the user has activated the trigger 214, the handset 18 begins the injection process by moving the injection rod 158 in the direction D and into contact with the plunger 522 of the cartridge 498. The injection rod 158 continues to move in the direction D ( Figure 2 ), thereby causing the drug contained in the cartridge 498 to be injected into the patient's body through the injection needle 418.

[0083] At a predetermined point during the injection process, the release member 174 of the injection rod 158 comes into contact with the locking pawl 182 of the needle body 438. As the injection rod 158 continues to move in direction D, the release member 174 biases the locking pawl 182 out of the locked position and into the unlocked position, thereby releasing the receiver 478.

[0084] After release and under the biasing force provided by the spring 490, the receiver 478 is biased away from the injection position and biased toward the withdrawal position, thereby causing the tip 482 of the injection needle 418 to be removed from the patient independently of the electrode 142. Specifically, the receiver 478 will be retracted toward the withdrawal position together with the injection rod 158, and the receiver 478 remains in contact with the injection rod 158 and biased against it. Once the receiver 478 approaches the withdrawal position, the locking aperture 493 becomes aligned with the locking pin 492. Once aligned, the locking pin 492 is biased into the locking aperture 493 and the locking position. In this way, in the withdrawal position, the receiver 478 is fixed relative to the needle body 438. In this configuration, even under the biasing pressure from the injection rod 158, the receiver 478 cannot return to the injection position.

[0085] With injection needle 418 withdrawn, handset 18 may then apply an electroporation signal to the target tissue through electrodes 142 to cause electroporation in the target tissue cells. More specifically, power source 24 provides power to signal generator 28, which in turn is in electrical communication with electrodes 142 of array 22.

[0086] Although shown for use with array 22, it should be understood that needle retraction and locking as described above may be achieved in other situations utilizing sharp instruments, such as needles and electrodes.

[0087] like Figure 4As shown, the receiver 478 also includes a cartridge lock 500 to secure the cartridge 498 within the injection assembly 442 so that it cannot be removed. More specifically, the cartridge lock 500 includes a stopper that allows the cartridge 498 to be axially inserted into the receiver 478 until the cartridge 498 reaches a predetermined position (i.e., makes contact with the needle 418), at which time the lock 500 engages the cartridge 498 and restricts its removal. The cartridge lock 500 operates independently of other locking mechanisms and ensures that any one cartridge 498 can only be used once, and avoids situations where a cartridge 498 that has been penetrated by the needle 418 may be inadvertently removed from engagement with the needle 418.

[0088] The foregoing description of specific aspects will fully disclose the general characteristics of the present invention so that others, by applying the knowledge in the art, can easily modify and / or change these specific embodiments for various applications without undue experimentation and without departing from the general concept of the present invention. Therefore, based on the teachings and guidance presented herein, these adaptations and modifications are intended to be within the meaning and scope of equivalents of the disclosed aspects. It should be understood that the wording or terminology herein is for the purpose of description rather than limitation, so that the terms or wording of this specification should be interpreted by those skilled in the art according to the teachings and guidance.

[0089] The breadth and scope of the present disclosure should not be limited by any of the above-described exemplary embodiments, but should be defined only in accordance with the following claims and their equivalents.

[0090] All publications, patents, patent applications and / or other documents cited in this application are incorporated by reference in their entirety for all purposes to the same extent as if each individual publication, patent, patent application and / or other document was individually indicated to be incorporated by reference for all purposes.

[0091] For the sake of completeness, various aspects of the invention are listed in the following numbered clauses:

[0092] Clause 1. An electroporation device comprising:

[0093] A handset, the handset comprising:

[0094] a housing defining a mounting point, and

[0095] a signal generator positioned within the housing; and

[0096] a needle array removably coupled to the mounting point and in electrical communication with the signal generator when the needle array is coupled to the mounting point, the needle array comprising:

[0097] main body,

[0098] a shield movable relative to the body between a rest position and one or more actuated positions,

[0099] An automatic locking member adjustable between a locked configuration in which the shield is not movable relative to the body and an unlocked configuration in which the shield is movable relative to the body, and wherein biasing the shield from the rest position to the one or more actuated positions and back to the rest position adjusts the automatic locking member from the unlocked configuration to the locked configuration.

[0100] Clause 2. The electroporation device of Clause 1, wherein the body comprises one or more electrodes coupled thereto.

[0101] Clause 3. The electroporation device of Clause 1, wherein the body comprises one or more hypodermic needles coupled thereto.

[0102] Clause 4. The electroporation device of Clause 2, wherein at least a portion of the one or more electrodes extend outside of the shield when the shield is in the one or more actuated positions.

[0103] Clause 5. The electroporation device of Clause 4, wherein the one or more electrodes are positioned within the shield when the shield is in the rest position.

[0104] Clause 6. The electroporation device of Clause 1, further comprising a receptacle movable relative to the body between an injection position and a retracted position, the receptacle having a hypodermic needle extending therefrom.

[0105] Clause 7. The electroporation device of Clause 6, wherein at least a portion of the hypodermic needle is positioned outside of the shield when the receiver is in the injection position and the shield is in one or more actuated positions.

[0106] Clause 8. The electroporation device of Clause 6, wherein when the receiver is in the retracted position, the hypodermic needle is positioned within the shield regardless of the position of the shield.

[0107] Clause 9. The electroporation device of Clause 6, wherein the handset comprises a drive assembly.

[0108] Clause 10. The electroporation device of Clause 6, wherein the receptacle is sized to at least partially receive the cartridge therein.

[0109] Clause 11. An electroporation device comprising:

[0110] A handheld device comprising:

[0111] a housing defining a mounting point,

[0112] Power supply, and

[0113] a signal generator in electrical communication with the power source; and

[0114] a needle array releasably coupled to the mounting point of the housing, the needle array comprising:

[0115] main body,

[0116] one or more electrodes coupled to the body,

[0117] a shield movable relative to the body between a rest position and one or more actuated positions, and wherein at least a portion of the one or more electrodes are positioned outside of the shield when the shield is in each of the one or more actuated positions,

[0118] a receiver movable relative to the body between an injection position and a retracted position, the receiver having a hypodermic needle extending therefrom; and

[0119] A locking pin is coupled to one of the body and the receiver and is movable relative thereto between a locked position and an unlocked position, wherein the receiver is fixed relative to the body in the locked position and the receiver is movable relative to the body in the unlocked position, and wherein the locking pin is biased toward the locked position so that when the receiver is positioned in a predetermined position relative to the body, the locking pin moves to the locked position.

[0120] Clause 12. The electroporation device of Clause 11, wherein the locking pin is coupled to one of the body and the receiver, and wherein the other of the body and the receiver defines a locking aperture.

[0121] Clause 13. The electroporation device of Clause 12, wherein the locking pin moves from the unlocked position to the locked position when the locking pin is axially aligned with the locking aperture.

[0122] Item 14. An electroporation device as described in Item 11, which also includes an automatic locking member that can be adjusted between a locked configuration and an unlocked configuration, wherein the shield cannot move relative to the body in the locked configuration, and the shield can move relative to the body in the unlocked configuration, and wherein biasing the shield from the rest position to the one or more actuated positions and back to the rest position adjusts the automatic locking member from the unlocked configuration to the locked configuration.

[0123] Clause 15. The electroporation device of Clause 11, wherein the needle array is in electrical communication with the signal generator when the needle array is coupled to the mounting point of the housing.

[0124] Clause 16. The electroporation device of Clause 11, wherein the receptacle is sized to receive at least a portion of a cartridge therein, and wherein the cartridge is in fluid communication with the hypodermic needle when inserted into the receptacle.

[0125] Clause 17. The electroporation device of Clause 16, further comprising a cartridge lock, and wherein the cartridge lock permits insertion of the cartridge into the receptacle but does not permit removal of the cartridge from the receptacle.

[0126] Clause 18. The electroporation device of Clause 11, wherein the body comprises a locking pawl configured to selectively retain the receiver in the injection position.

[0127] Clause 19. The electroporation device of Clause 18, wherein the handset includes a drive assembly, and wherein the drive assembly includes a release member configured to engage the locking pawl and allow the receiver to move from the injection position toward the retracted position.

[0128] Clause 20. An electroporation system for performing electroporation therapy, the system comprising:

[0129] Base station;

[0130] A handset, which is movably connected to the base station, the handset comprising:

[0131] a housing having a mounting member formed thereon,

[0132] a power source positioned within the housing,

[0133] an injection assembly having a release member thereon; and

[0134] a needle array releasably coupled to a mounting member of the housing, the needle array comprising:

[0135] main body,

[0136] one or more electrodes coupled to the body,

[0137] a shield movable relative to the body between a rest position and one or more actuated positions, and wherein at least a portion of the one or more electrodes is exposed when the shield is in the one or more actuated positions, and

[0138] An automatic locking member adjustable between a locked configuration in which the shield is not movable relative to the body and an unlocked configuration in which the shield is movable relative to the body, and wherein biasing the shield from the rest position to the one or more actuated positions and back to the rest position adjusts the automatic locking member from the unlocked configuration to the locked configuration.

Claims

1. A needle array for an electroporation device, comprising: The body has a locking surface, a shield movable relative to the body between a rest position and one or more actuated positions along an axial direction oriented along a central axis of the needle array, and an automatic locking member including a resilient body coupled to the shield and movable with the shield, the automatic locking member being spaced apart from the central axis in a direction perpendicular to the central axis, wherein the automatic locking member is adjustable between a locked configuration and an unlocked configuration, In the locked configuration the shield is immovable relative to the body and the proximal end of the resilient body is bent in a first direction perpendicular to the direction and the axial direction, and In the unlocked configuration the shield is movable relative to the body, wherein biasing the shield from the rest position to the one or more actuated positions and back to the rest position adjusts the automatic locking member from the unlocked configuration to the locked configuration, so that as the automatic locking member is adjusted from the unlocked configuration to the locked configuration, the biasing force biases the proximal end of the elastic body in a second direction opposite to the first direction, wherein in the locked configuration, the elastic body engages with the locking surface.

2. The needle array of claim 1, wherein the body includes one or more electrodes coupled thereto.

3. The needle array of claim 1, wherein the body comprises one or more hypodermic needles coupled thereto.

4. The needle array of claim 2, wherein at least a portion of the one or more electrodes extend outside of the shield when the shield is in the one or more actuated positions.

5. The needle array of claim 4, wherein the one or more electrodes are positioned within the shield when the shield is in the rest position.

6. The needle array of claim 4, wherein the shield defines a contact plate at a distal end of the shield, the contact plate being configured to be pressed against a patient to cause the shield to move from the rest position toward the one or more actuated positions.

7. A needle array as described in claim 6, wherein the contact plate defines one or more orifices such that movement of the shield from the static position toward the one or more actuated positions causes each tip of the one or more electrodes to pass through a corresponding one of the one or more orifices.

8. A needle array as described in claim 7, wherein the contact plate defines one or more other orifices such that movement of the shield from the static position toward the one or more actuated positions causes portions of one or more subcutaneous injection needles to pass through a corresponding one of the one or more other orifices.

9. The needle array of claim 1 further comprising a receiver movable relative to the body between an injection position and a retracted position, the receiver having a hypodermic needle extending therefrom.

10. The needle array of claim 9, wherein at least a portion of the hypodermic needle is positioned outside of the shield when the receiver is in the injection position and the shield is in the one or more actuated positions.

11. The needle array of claim 9, wherein when the receiver is in the retracted position, the hypodermic needle is positioned within the shield regardless of the position of the shield.

12. The needle array of claim 9, wherein the receptacle is sized to at least partially receive a cartridge therein.

13. The needle array of claim 12, further comprising a locking pin connected to the body and one of the receivers, wherein the locking pin is movable relative to the body and one of the receivers between a locked position and an unlocked position, wherein the receiver is fixed relative to the body in the locked position and the receiver is movable relative to the body in the unlocked position.

14. The needle array of claim 13, wherein the locking pin is biased toward the locking position such that the locking pin moves into the locking position when the receiver is positioned in a predetermined position relative to the body.

15. The needle array of claim 14, wherein the locking pin is coupled to one of the body and the receiver, and wherein the other of the body and the receiver defines a locking aperture.

16. The needle array of claim 15, wherein the locking pin moves from the unlocked position to the locked position when the locking pin is axially aligned with the locking aperture.

17. The needle array of claim 14, wherein the cartridge is in fluid communication with the hypodermic needle when inserted into the receptacle.

18. The needle array of claim 17, further comprising a cartridge lock, and wherein the cartridge lock permits insertion of the cartridge into the receiver but does not permit removal of the cartridge from the receiver.

19. The needle array of claim 14, wherein the body includes a locking pawl configured to selectively retain the receiver in the injection position.

20. The needle array of claim 19, wherein the locking pawl is configured to move toward an unlocked position, wherein the receiver is permitted to move from the injection position toward the retracted position.

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